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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649506 |
Purpose
The objective of this study was to evaluate the relative bioavailability of Mylan's nitrofurantoin macrocrystals 100 mg capsules to Procter & Gamble's Macrodantin® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco using volunteers under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Nitrofurantoin Macrocrystals 100 mg Capsules Drug: Macrodantin® 100 mg Capsules |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Food In Relative Bioavailability Study of Mylan Nitrofurantoin Macrocrystals 100 mg Capsules and Procter & Gamble Macrodantin® 100 mg Capsules in Healthy Volunteers |
| Enrollment: | 28 |
| Study Start Date: | September 2003 |
| Study Completion Date: | September 2003 |
| Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Nitrofurantoin Macrocrystals 100 mg Capsules
|
Drug: Nitrofurantoin Macrocrystals 100 mg Capsules
100mg, single dose fed
|
|
2: Active Comparator
Macrodantin® 100 mg Capsules
|
Drug: Macrodantin® 100 mg Capsules
100mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:
Note: Hormonal contraceptives are NOT an acceptable form of contraception in this study.
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Thomas S Clark, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | NITF-0324 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649506 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Anti-Infective Agents Nitrofurantoin Therapeutic Uses |
Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |